Medlite C6

GUDID 00841494100193

Medlite C6 115V Laser Assembly

Cynosure, Inc.

Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system

Primary Device ID	00841494100193
NIH Device Record Key	50dcc34a-cdb1-4dcb-a4f8-f3e5e02c7e1a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Medlite C6
Version Model Number	659-0020-1
Company DUNS	780318028
Company Name	Cynosure, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841494100193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K014234

FDA Product Code

GEX	Powered laser surgical instrument

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-24

On-Brand Devices [Medlite C6]

00841494100209	Medlite C6 220V Laser Assembly
00841494100193	Medlite C6 115V Laser Assembly